proof of concept study of sar443122 in patients with cutaneous lupus erythematosus

Conditions: Cutaneous Lupus Erythematosus

Summary: primary objective: * assess the efficacy of sar443122 in cutaneous lupus erythematosus (cle) secondary objectives: * assess the effect of sar443122 on the physician's global assessment of disease activity (physga - disease activity) * assess the effect of sar443122 on cle induced itch and overall pain * assess the effect of sar443122 on the proportion of disease activity responders compared to placebo * assess the effect of sar443122 on the clasi components score * assess the effect of sar443122 on the investigator's global assessment for cle (iga-cle) * assess oral cavities for patients with oral lesions * assess the disease specific quality of life (qol) * assess the safety and tolerability of sar443122 in patients with cle * assess the pharmacokinetics (pk) exposure of sar443122 in patients with cle

total study duration per participant was up 20 weeks including: * a screening period of up to 4 weeks * a treatment period of 12 weeks * a post treatment follow-up period of 4 weeks

Eligibility criteria:
inclusion criteria : * participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before screening. * participants with histologically confirmed and documented diagnosis within one year prior to screening or during screening period prior to randomization. * active cutaneous lupus erythematosus skin lesions and a cutaneous erythematosus. * disease area and severity index activity (clasi-a) ≥10 both at screening and baseline. * participant who was candidate for systemic treatment per investigator's judgement. exclusion criteria: * systemic lupus erythematosus according to the 2012 slicc criteria with major organ involvement. * suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests. * autoimmune disease(s) other than systemic lupus erythematosus. * active skin diseases that may interfere with the study or study assessments. * exclusion related to tuberculosis, non-tuberculous mycobacterial infections, hiv, hbv, hcv, herpes zoster, covid-19 and other recurrent or recent serious infections. * prolonged qtcf ≥ 450 ms (by fridericia formula) or clinically significant findings on electrocardiogram (ecg). * cannot avoid excessive uv exposure 4 weeks prior to baseline and during the study. routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study. * concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit. * initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to screening visit (or during screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine. * systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication. * systemic corticosteroids treatment \<4 weeks before baseline visit. * live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study. * laboratory abnormalities at the screening visit. the above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.